A bipartisan effort to slow the number of drug shortages in recent years, that have often left federal officials scrambling for last-minute solutions, was approved in the House.
The bill, part of the Food and Drug Administration Reform Act, sponsored by Reps. Tom Rooney, R-Tequesta, and Diana DeGette, D-Colo., would establish an early warning system for patients and physicians by requiring drug companies to notify the FDA of impending shortages.
A similar effort was approved by the Senate last week; at the same time, they rejected a proposal by Sen. Al Franken, D-Minn., to allow the importation of low-cost Canadian prescriptions.
Since 2005, drug shortages have tripled. Potential solutions have been considered that include a national drug stockpile to an overhaul of how rare drugs are priced.
I started working on drug-shortage legislation more than a year ago after meeting with doctors and hospital administrators at Charlotte County Regional Medical Center, who told me they were facing shortages of critical, lifesaving drugs, and we needed to act, Rooney stated in a release.
By giving doctors, suppliers and the FDAan early notice about a potential shortage, we can help them respond and even prevent disruptions from occurring.
Rep. Fred Upton, R-Minn., chairman of the House Energy and Commerce Committee, called DeGette and Rooney real leaders in the effort to address the issue of drug shortages.
Throughout this crisis Ive talked to patients battling devastating diseases like cancer, who show up for treatment one day, only to find out their lifesaving drugs are not available, DeGette stated in a release.
Late last year, the White House issued an executive order seeking voluntary compliance from drug makers to give advance warnings when supplies are expected to dwindle. The White House has claimed the order has reduced the number of shortages to 42 this year, down from 90 a year ago at the same time.
The Rooney-DeGette act -- endorsed by groups including the American Hospital Association, the American Medical Association, American Society of Health-System Pharmacists, the American Cancer Society, the National Association of Childrens Hospitals, and generic drug manufacturer Hospira Inc. -- would:
Require manufacturers of prescription drugs, including biologics, to notify the FDA of any discontinuance or interruption in the production of a drug at least six months in advance or as soon as practicable.
Instruct the secretary to distribute this information to appropriate health care providers and patient organizations.
Authorize the GAO to conduct a study to examine the causes of drug shortages and issue recommendations on how to prevent or alleviate a drug shortage.
Reach Jim Turner at jturner@sunshinestatenews.com or at (772) 215-9889.
